Industry News

Astellas Pharma US, Inc. reaches agreement with U.S. Department of Justice

Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that it has reached an agreement with the U.S. Department of Justice to resolve civil claims regarding the marketing of MYCAMINE® (micafungin sodium) for injection. 
 

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ALK announces FDA approval for Merck’s ragweed sublingual allergy immunotherapy tablet RAGWITEK

Copenhagen, 2014-04-17 20:58 CEST (GLOBE NEWSWIRE) -
ALK today announced that the US Food and Drug Administration (FDA) has approved the Biologic License Application (BLA) for RAGWITEK

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Batches of Herceptin Could Have Been Tampered With and Reintroduced into Supply Chain, EMA Reports

The European Medicines Agency is reporting that vials of the cancer medicine Herceptin (trastuzumab) are believed to have been stolen in Italy, tampered with, and reintroduced into the supply chain in some countries. Authorities in Italy are investigating, and healthcare professionals throughout the European Union are being notified, EMA reports. Affected Herceptin batches identified are numbered H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09, and H4303B01.

Aesica Serializing Two Allergy Products for China

Global pharmaceutical contract developer and manufacturer Aesica reports that it has introduced serialization services and begun commercial production of two anti-allergy product lines for the Chinese market at its Pianezza site, Italy, for a global, multinational client. The implementation took under six months to complete, with the first production of serialization batches just commenced, the company reports.

Sterile Medical Packaging, Global Distribution on the Agenda at LifePack Forum Debuting in China

LifePack Forum Inc. will host a healthcare product packaging seminar and exhibitor showcase May 6 & 7, 2014, in Suzhou, China at the Suzhou Marriott Hotel, Gusu District. The event seeks to help solve the challenges faced by packaging professionals in China, show organizers report.

Sponsored by Eastman Chemical Company and Steripack, the event will cover the following topics:

FDA Approves Expanded Indication for Certain Pacemakers and Defibrillators Used to Treat Heart Failure

The U.S. Food and Drug Administration today approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.

Covidien Implements Voluntary Recall of its Pipeline Embolization Device and Alligator Retrieval Device

Covidien plc today announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.
 
PTFE coating is used to reduce friction between devices and ease navigation through the vasculature.

Compliance Package Innovations Recognized by the Healthcare Compliance Packaging Council

The Healthcare Compliance Packaging Council (HCPC) announced the winners of its annual Compliance Package of the Year competition at RxAdherence 2014. The annual competition celebrates package innovations designed to improve patient adherence.

This year’s winners are:

• 2013 Compliance Package of the Year: Noven Therapeutics Brisdelle in MWV Dosepak from PCI (Packaging Coordinators, Inc)

• Compliance Package of the Year First Runner Up: Depomed Gralise Starter Pack from PCI

Focus on the End-User

Package usability was a distinct theme at HealthPack this year. Not only did attendees get to hear the “voice of the customer” during the event’s annual nurses panel, but also a few speakers urged attendees to examine the end-user experience when designing medical device packaging.

Vetter launches new clinical syringe packages

Deck: 

Earlier syringe development may cut time-to-market, increase clinical trial appeal

Vetter, a leading contract development and manufacturing organization (CDMO), introduced two clinical syringe packages that make it easier to start syringe development earlier in the drug development process. Starting syringe work earlier, in full or partial parallel with vial development, can cut up to 18 months off time-to-market.

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